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Drug Facts
Theracare Pain Relieving Menthol Gel
FDA Label NDC 71101-015
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Veridian Healthcare for the product Theracare Pain Relieving Menthol Gel (NDC 71101-015). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, when using this product, do not, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Menthol 2%
Purpose
- Topical Analgesic
Uses
Uses Temporary relief from minor aches and pains of sore muscles and joints associated with:
■arthritis ■backache ■strains■sprains
Warnings
For external use only
When Using This Product, Do Not
When using this product:
■ do not use with other topical pain relievers
■do not use with a heating pads or other heating devices
■ avoid contact with eyes
■do not bandage tightly
■ do not apply to wounds or damaged skin
Stop Use And Ask A Doctor If
Stop use and ask a doctor if: the condition worsens, or if symptoms persist for more than 7 days or clear up and occur again withing a few days.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding,ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental ingestion, get medical help orcontact a Poison Control Center (800-222-1222) right away.
Directions
Directions
- clean affected area before applying product
- Adults and children 2 years of age and older apply to the affected area not more than 3 to 4 times daily
- Children under 2 years of age, ask a doctor before using this product
Other Information
- do not freeze
- store at room temperature
- keep container tightly closed when not in use
- do not use, pour, spill or store near heat or open flame
Inactive Ingredients
ammonium hydroxide, carbomer, cupric sulfate, FD&C blue No. 1, Isopropyl alcohol, magnesium sulphate anhydrous, sodium hydroxide, thymol, water
Theracare Pain Relieving Menthol Gel
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